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Validation of Computer Systems: Pharmaceutical Manufacturing

  November 19, 2007  
The Center for Professional Advancement, Amsterdam, The Netherlands
3-5 March 2008

Who Should Attend
This course will be of particular value to individuals responsible for:
  • System Quality Control
  • System Management and Development
  • Computer System Validation

Recent problems associated with computer inaccuracies have led the FDA to pressure the pharmaceutical and blood processing industries into adoption of rigid standards of system validation and testing. The application of a testing methodology is of particular importance in design, operation and quality control of manufacturing systems, where computers are integrally used in product control and inventory tracking.

This course is designed to provide the necessary skills for mastering the principles and techniques of developing and implementing a system validation and testing plan for manufacturing-related computer systems. The course uses a combination of lecture/discussions, case studies, “role-play actors,” and multimedia presentations to provide a living case of a computerized pharmaceutical system in need of a validation plan for cGMP information systems. The program will take participants step-by-step through the process of developing and implementing that plan, and will conclude with a session adapting the plan to each participant’s unique environment and products.

Features of the Course Include:

  • Specification of a methodology for meeting FDA and PMA guidelines for manufacturing systems involving computers
  • Practical experience in applying that methodology to actual computerized manufacturing systems
  • New update on 21 CFR Part 11

Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Sandy Weinberg; Vice President, Regulatory, Tikvah Therapeutics

Dr. Sandy Weinberg VP, Regulatory, TIKVAH Therapeutics, is former Sr. Director, Fast Trak Vaccines, GE Healthcare and has been the leader in the field of system validation for more than twenty years. He has consulted to the FDA, most other regulatory agencies worldwide, and the industry on techniques for assuring data quality and control since first identifying significant data problems in 1976. Dr. Weinberg is the author of numerous system validation books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, and System Validation Annual.His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.

Dr. Weinberg served as a professor of biomedical informatics at Muhlenberg College in Allentown, Pennsylvania, USA. He is also a member of the board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands, and an investor in and board member of several international biomedical companies.

Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas related to system validation. Recent projects include the auditing and certification of a chromotography control system; auditing and advisory services related to a pharmaceutical inventory system; and validation of a Laboratory Information Management System (LIMS). Much of Dr. Weinberg’s practice is centered in Western Europe and Israel.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: info@cfpa.com
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